Back to resultsESWT for UE Pain in Patients With Cervical Spinal Cord Injury
Primary Purpose
Spastic Tetraplegia, Pain, Myelopathy Cervical
Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Extracorporeal shockwave therapy
Sham therapy
Sponsored by
About this trial
This is an interventional treatment trial for Spastic Tetraplegia focused on measuring Extracorporeal shockwave therapy, Cervical myelopathy, Spasticity, Pain
Eligibility Criteria
Inclusion Criteria:
- Spinal cord damage confirmed in the spinal cord image
- 1 month after spinal cord injury
- Spasticity of upper extremities
- Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)
- Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
- Age: 20 and older
- Person who has agreed in writing to decide his or her participation and comply with the precautions
Exclusion Criteria:
- Pain due to trauma
- Injection treatments two weeks before participating in the study
- Severe coagulopathy (excluding antiplatelet use)
- Impaired cognition
Sites / Locations
- Department of Rehabilitation Medicine, CHA Bundang Medical Center,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
Sham therapy
Outcomes
Primary Outcome Measures
Numerical rating scale (NRS)
Pain intensity (0-10, ordinal scale)
Secondary Outcome Measures
Modified Ashworth scale (MAS)
Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)
Range of motion (ROM)
Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range)
Grasp power
Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04319679
Brief Title
ESWT for UE Pain in Patients With Cervical Spinal Cord Injury
Official Title
The Effects of Extracorporeal Shockwave Therapy (ESWT) for Upper Extremity Pain Related to Spasticity in Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruiting patients
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
April 5, 2021 (Actual)
Study Completion Date
April 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (ESWT) for upper extremity pain related to spasticity in patients with spinal cord injury.
Detailed Description
6 times of ESWT (3,000 pulses per time, low energy under 0.3 mJ/m^2, tolerable range) on forearm area to reduce pain related to spasticity in patients with cervical myelopathy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Tetraplegia, Pain, Myelopathy Cervical
Keywords
Extracorporeal shockwave therapy, Cervical myelopathy, Spasticity, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
3,000 pulses per time, low energy under 0.3 mJ/mm^2, tolerable range
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Sham therapy
Intervention Type
Device
Intervention Name(s)
Extracorporeal shockwave therapy
Intervention Description
6 times during 2 weeks
Intervention Type
Device
Intervention Name(s)
Sham therapy
Intervention Description
6 times during 2 weeks
Primary Outcome Measure Information:
Title
Numerical rating scale (NRS)
Description
Pain intensity (0-10, ordinal scale)
Time Frame
Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Secondary Outcome Measure Information:
Title
Modified Ashworth scale (MAS)
Description
Spasticity, ordinal scale (0, 1, 1+, 2, 3, 4: higher scores indicate more severe spasticity)
Time Frame
Up to 4 weeks (baseline, after each treatment during 2 weeks, 2 weeks + 1 day, 4 weeks)
Title
Range of motion (ROM)
Description
Passive ROM of elbow, wrist and 3rd finger (in degrees: higher scores indicate larger range)
Time Frame
Up to 4 weeks (baseline, 1 week, 2 weeks, 2 weeks + 1 day, 4 weeks)
Title
Grasp power
Description
Hand grip power (in Kg measured by a dynamometer: higher scores indicate stronger power)
Time Frame
Up to 4 weeks (baseline, 2 weeks, 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Spinal cord damage confirmed in the spinal cord image
1 month after spinal cord injury
Spasticity of upper extremities
Pain in areas below spinal cord injury more than 4 points on the numerical scale (NRS)
Cognitive functions that can clearly point out NRS with more than 15 points in the mini mental state examination (MMSE)
Age: 20 and older
Person who has agreed in writing to decide his or her participation and comply with the precautions
Exclusion Criteria:
Pain due to trauma
Injection treatments two weeks before participating in the study
Severe coagulopathy (excluding antiplatelet use)
Impaired cognition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyunghoon Min, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, CHA Bundang Medical Center, CHA University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine, CHA Bundang Medical Center,
City
Seongnam
ZIP/Postal Code
13496
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Information that cannot be identified
Learn more about this trial
ESWT for UE Pain in Patients With Cervical Spinal Cord Injury
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